RecruitingPhase 4NCT06613854

Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes

Effect of Early Combination Antihyperglycemic Treatment With Metformin and Oral Semaglutide vs. Metformin and Empagliflozin on Glycemic and Metabolic Control in Individuals With Short Duration Type 2 Diabetes


Sponsor

University Medical Centre Ljubljana

Enrollment

90 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes. It will also learn about the effect of the combination treatment on body weight, body composition, blood lipids, oxidative stress, inflammation, metabolic control, insulin resistance and insulin secretion from pancreas, together with its safety profile. The main questions it aims to answer are: * Does early combination with two antidiabetic drugs improve blood glucose levels, determined by continuous glucose monitoring system? * Is early combination treatment as safe as treatment with a single antidiabetic drug? * Does early combination treatment reduces the need for rescue therapy? * Does early combination treatment reduces body weight and improves body composition? * Does early combination treatment improves blood lipid parameters, oxidative stress and inflammation? * Does early combination treatment improves metabolic parameters? * Does early combination treatment improves insulin resistance and insulin secretion? Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes. Participants will: * Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks. * Visit the clinic four times during the study duration for checkups and tests. * Carry a continuous glucose monitoring sensor for 14 days prior to study visits.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether starting combination diabetes medications early — rather than a single drug — leads to better blood sugar control in people newly diagnosed with type 2 diabetes. Most people start on metformin alone; this trial asks whether adding another drug right away produces better long-term results. **You may be eligible if...** - You have been diagnosed with type 2 diabetes within the last 2 years - You are between 18 and 70 years old - Your HbA1c (average blood sugar level) is 8.0% or below - You are currently taking metformin at a dose of at least 1,500 mg per day **You may NOT be eligible if...** - You have type 1 diabetes or a specific rare form of diabetes (like MODY or LADA) - You have significant kidney, liver, or heart problems - You are pregnant or planning to become pregnant - You have already been on other diabetes medications besides metformin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral semaglutide

Semaglutide Oral Tablets will be introduced to the Oral Semaglutide Arm as per protocol for regular therapy introduction.

DRUGEmpagliflozin 10 mg

Empagliflozin Oral Tablets will be introduced to the Empagliflozin Arm as per protocol for regular therapy introduction.


Locations(1)

University Medical Centre Ljubljana, Diabetes Outpatient Clinic

Ljubljana, Slovenia

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NCT06613854


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